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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011444
Receipt No. R000013396
Scientific Title Before-after study of a transcranial direct current stimulation (tDCS) effects for rehabilitative treatments in subacute brain damaged patients
Date of disclosure of the study information 2013/08/11
Last modified on 2016/12/26

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Basic information
Public title Before-after study of a transcranial direct current stimulation (tDCS) effects for rehabilitative treatments in subacute brain damaged patients
Acronym Effects of a transcranial direct current stimulation (tDCS) in rehabilitative treatments
Scientific Title Before-after study of a transcranial direct current stimulation (tDCS) effects for rehabilitative treatments in subacute brain damaged patients
Scientific Title:Acronym Effects of a transcranial direct current stimulation (tDCS) in rehabilitative treatments
Region
Japan

Condition
Condition Cerebrovascular disease, Traumatic brain injury
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effects of a transcranial direct current stimulation on rehabilitative task achievement in subacute brain damaged patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Rehabilitative task achievement: 1) Higher brain disorders; Clinical assessment for attention, Naming task, 2) Motor palsy; Dexterity, Ankle movement, Standing balance, 3) Dysphagia; Swallowing reflex velocity
Key secondary outcomes Effects on learning skills (Digit span, Tapping span, Repetitive tests of body sways), Safety (Questionnaire surveying for tDCS adverse effects)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Transcranial direct current stimulation (2mA intensity for 20 minutes once a day for 5 consecutive days)
Interventions/Control_2 Sham transcranial direct current stimulation (20 minutes once a day for 5 consecutive days)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients admitted for cerebrovascular disease or traumatic brain injury treatments within 2 months and required rehabilitative treatments to higher brain disorders such as inattention and aphasia, motor palsy, or dysphagia.
Key exclusion criteria Brain surgery to the tDCS stimulation sites,
History of seizure,
History of other brain diseases,
Epicardial pacemaker implantation
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimitaka Hase
Organization Kansai Medical University Hirakata Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 2-3-1 Shinmachi, Hirakata, Osaka
TEL 072-804-2780
Email hasekim@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kimitaka Hase
Organization Kansai Medical University Hirakata Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address hasekim@hirakata.kmu.ac.jp
TEL 072-804-2780
Homepage URL
Email hasekim@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University Hirakata Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 関西医科大学附属枚方病院(大阪府)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 11 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www7.kmu.ac.jp/rehab/research/
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2013 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 12 Day
Last follow-up date
2016 Year 12 Month 25 Day
Date of closure to data entry
2016 Year 12 Month 26 Day
Date trial data considered complete
2016 Year 12 Month 26 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 08 Month 10 Day
Last modified on
2016 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013396

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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